Catalent plans $100 million biologics manufacturing expansion at Anagni

Catalent has announced that it is planning a $100 million expansion program at its facility in Anagni, Italy, to add biologics drug substance manufacturing capabilities, as European demand for biologics manufacture and supply continues to grow.

Two 2,000-liter single-use bioreactors will be installed within new, purpose-built manufacturing suites as part of the initial phase of the expansion, along with associated investments to support early-phase clinical development and late-stage and commercial tech transfers.

It will also include the creation of the infrastructure required for a further six 2,000-liter single-use bioreactors.

The initial expansion is expected to be operational for customer projects in April 2023 and will increase the site’s workforce by up to 100 employees.

Later phases of the planned expansion are planned to include the provision of 16,000 liters of total flexible manufacturing capacity, enabling 2,000-liter to 8,000-liter batch production scale.

Catalent’s Anagni site, which it acquired in January 2020, is a biologics and oral dose manufacturing facility that specializes in late-stage and commercial product launches. It is currently being used to fill vials of the Astra Zeneca and Johnson & Johnson COVID-19 vaccines.

“Catalent was an early adopter of single-use technology because of its flexibility, and we continue to invest in technology that enables adaptable, scalable solutions for the fast-growing segment of biologics addressing mid-sized and orphan patient populations,” said Mario Gargiulo, Catalent’s Region President, Biologics, Europe.